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Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01132352
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.


Condition Intervention Phase
Healthy
 Drug: Levetiracetam
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioavailability based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2003
Study Completion Date: November 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
 Drug: Levetiracetam
Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Other Name: Keppra® 750 mg Tablets
Active Comparator: Keppra®
Keppra® 750 mg Tablets of UCB Pharma Inc.,
 Drug: Levetiracetam
Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Other Name: Keppra® 750 mg Tablets

Detailed Description:

This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fed conditions with a washout period of 7 days.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult male volunteers, 18 to 55 years of age;
  • Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
  • Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
  • Voluntarily consent to participate in the study

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

  • In addition, history or presence of:

    1. alcoholism or drug abuse within the past 2 years;
    2. hypersensitivity or idiosyncratic reaction to levetiracetam;
  • Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
  • Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
  • Subjects who have made a plasma donation within 7 days prior to the first dose.
  • Subjects who have participated in another clinical trial within 30 days prior to the first dose.
  • Subjects with hemoglobin less than 12.0 g/dL.
  • Subjects who have participated in another clinical trial within 30 days prior to the first dose.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132352

Locations
United States, New Jersey
MDS Pharma Services
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Magdy L Shenouda, MD MDS Pharma Services
  More Information

No publications provided

Responsible Party: Mr. M.S. Mohan / Senior Manager - R&D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01132352     History of Changes
Other Study ID Numbers: AA06209
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioavailability
Crossover
Levetiracetam

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013